[Data management for clinical trials at the data center].
Data Management is a series of procedures and a research field which assure the quality control in clinical trials. Poorly performed data management can cause various biases in the results of clinical trials. Data management is important especially in cancer clinical trials because of their multiple endpoints, dealing with multiple therapeutic drugs and modalities. Data checks performed by data center staff and composed of manual and computer checks are the main procedures in data management. It is most important that all participants of clinical trials, physicians, nurses, biostatisticians and data managers, understand the data management processes and collaborate with one other from the earliest stage of conducting clinical trials.
Niimi
M
M
Graduate School of Medicine, University of Tsukuba.
Fukuda
H
H
Yamamoto
S
S
Okuyama
S
S
Yamaguchi
N
N
D001699:Biometry; D002986:Clinical Trials as Topic; D003627:Data Interpretation, Statistical; D006801:Humans; D009369:Neoplasms / Q000401:mortality / Q000628:therapy*; D011786:Quality Control; D012107:Research Design; D015996:Survival Rate